Process Engineer IV

Curia • Albuquerque, NM

405d

About The Position

The Process Engineer IV will execute and oversee advanced engineering functions such as process design, scale-up, and meticulous documentation control. This position will collaborate closely with cross-functional teams, including R&D, Quality Assurance, and Production, providing technical leadership and expertise to drive process improvements, enhance operational efficiency, and ensure compliance with industry standards such as cGMP and FDA regulations.

Requirements

• Bachelor's degree in Biology, Chemical Engineering, or a related field.
• Minimum eight (8) years' experience in a cGMP/FDA, regulated environment.
• Experience with aseptic fill/finish, preferred.

Responsibilities

• Develop batch records for client-specific formulation and filling operations.
• Oversee processing operations (ENG and GMP) including equipment preparation, bulk product formulation, sterile filtration, and filling support.
• Operate as an SME for GMP investigations (e.g. CAPA, departures, CCRs) and finalize closure reports for departures assigned to process engineering.
• Direct client interaction for routine discussions, summarizing engineering-related work completed verbally and in writing.
• Identify and specify process-specific equipment needed for clients' tech transfer.
• Develop techniques and process parameters specific to the client's product while maintaining critical product attributes.
• Author instructions for the operation of equipment and detailing process flows in the cleanroom facility.
• Develop new manufacturing processes to meet client requirements.
• Adhere to safety requirements at all times and raise deviations in the process to the attention of the shift supervisor, engineering manager, and/or quality assurance.

What This Job Offers

• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Education Level: Bachelor's degree
• Number of Employees: 1,001-5,000 employees